Frame based unidirectional flow prosthetic implant

• US 7,758,632 B2
• Filed: 05/09/2003
• Issued: 07/20/2010
• Est. Priority Date: 05/10/2002
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Majercak, David Christopher, Hojeibane, Hikmat
• Primary Examiner(s): Nguyen; Anhtuan T
• Assistant Examiner(s): Sonnett; Kathleen
• Application Number:
  US10/434,891
• Publication Number:
  US 20040019374A1
• Time in Patent Office: 2,629 Days
• Field of Search: 623/1.1, 623 113- 117, 623 124- 126, 623/1.22, 623 211- 219, 623/2.2, 623/900, 623/1.11, 623/2.1, 623 222- 229, 606/194, 606/198, 606/200
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2002/91583 by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

The present invention relates to a medical device, and in particular, to a stent-based valve. The valve includes a radially expandable structural frame comprising a proximal and distal anchors formed from a lattice of interconnected elements, and having a substantially cylindrical configuration with first and second open ends and a longitudinal axis extending there between. One or more cantilevered valve struts are attached directly or indirectly to the proximal anchor. The stent based valve also comprises one or more connecting members attached between the proximal and distal anchors. A biocompatible valve assembly is coaxially disposed and attached to the proximal anchor and extends in the longitudinal direction along the one or more connecting members.

Claims

1. A prosthetic valve comprising:

a radially expandable structural frame having a substantially cylindrical configuration with first and second open ends and a longitudinal axis defining a longitudinal direction extending there between, the structural frame including a proximal anchor, a distal anchor, a plurality of connecting members, each connecting member oriented parallel to the longitudinal axis and connected between the proximal anchor and distal anchor at spaced apart intervals along the circumference of each anchor, one or more flex segments each having a first end, a second end and an intermediate region there between, the first and the second ends of each of the one or more flex segments being attached to the distal end of the proximal anchor, each of the one or more flex segments having a semicircular configuration with a circumferential length relative to the longitudinal axis that is less than the circumferential length of the distal end of the proximal anchor, each of the one or more flex segments being disconnected from the circumferentially adjacent one or more flex segments, and one or more cantilever valve struts, each cantilever valve strut having first and second ends, and being oriented parallel to the longitudinal axis when in their zero strain state, wherein the first end is attached to the intermediate region and the second end is free to be displaced when the valve is deployed in a body lumen; and

a tubular membrane attached to the abluminal surface of the proximal anchor and extending distally along the abluminal surface of the one or more connecting members, the tubular membrane having proximal and distal ends, and terminating with supple valve flaps, each supple valve flap being formed along the distal end between the one or more connecting members, wherein the distal end of the tubular membrane is engaged by the abluminal surface of the second end of the one or more cantilever valve struts.

2. The prosthetic valve of claim 1 wherein the structural frame comprises a material selected from the group consisting of stainless steel, tantalum, platinum alloys, niobium alloy, cobalt alloy, and nickel-titanium alloy.

3. The prosthetic valve of claim 1 wherein the structural frame comprises a polymer.

4. The prosthetic valve of claim 1 wherein the tubular membrane assembly is formed from a flexible membrane-like material.

5. The prosthetic valve of claim 4 wherein the membrane-like material is a biological material.

6. The prosthetic valve of claim 5 wherein the biological material is a vein.

7. The prosthetic valve of claim 4 wherein the membrane-like material is a synthetic material.

8. The prosthetic valve of claim 7 wherein the synthetic material is an elastomeric polymer.

9. The prosthetic valve of claim 7 wherein the synthetic material is a bioabsorbable material.

10. The prosthetic valve of claim 7 wherein the synthetic material further comprises a reinforcement fiber.

11. The prosthetic valve of claim 1 wherein the tubular membrane comprises one or more valve cusps.

12. The prosthetic valve of claim 1 wherein at least a portion of the structural frame is coated with an agent.

13. The prosthetic valve of claim 12 wherein the agent coating contains a therapeutic agent.

14. The prosthetic valve of claim 12 wherein the agent coating contains a pharmaceutic agent.

15. The prosthetic valve of claim 12 wherein the agent coating comprises an agent eluting layer.

16. The prosthetic valve of claim 1 wherein at least a portion of the tubular membrane is coated with an agent.

17. The prosthetic valve of claim 16 wherein the agent coating contains a therapeutic agent.

18. The prosthetic valve of claim 16 wherein the agent coating contains a pharmaceutic agent.

19. The prosthetic valve of claim 16 wherein the agent coating comprising an agent eluting layer.

20. The prosthetic valve of claim 1 wherein at least a portion of the tubular membrane is impregnated with a therapeutic agent.

21. The prosthetic valve of claim 1 wherein at least a portion of the tubular membrane is impregnated with a pharmaceutic agent.

22. The prosthetic valve of claim 1 wherein the cantilever valve strut has an undulating section between the first and the second ends.

23. The prosthetic valve of claim 1 wherein the second end of at least one of the one or more cantilever valve struts diverge into a plurality of distal branches.